Here is a link to the inventory.

The inventory has implications both for the economic value of nanotech investments (currently over $1 Billion in US federal funding alone), and also for the EHS (Environmental, Health, and Safety) dimenions of nanotech in society. We might think of these as conflicting understandings of “health” – one focused on economic health, the other on human and environmental health.

Not too long ago, a report “slammed” nanotech research and its funding for not delivering economically. The Wilson Center’s inventory may this reassure some as a contrary indicator.

On the other hand, Congress held hearings late last year and last month to explore EHS issues related to nanotech. The Wilson inventory may thus also raise alarms about health and safety.

An article in Friday’s Washington Post includes discussion of both of these dimensions of health. Here is an excerpt:

“The growing variety of nano-based consumer products “is what you’d hope for after a billion-dollar investment in this country,” said Vicki Colvin, director of the Center for Biological and Environmental Nanotechnology at Rice University in Houston. But with regulators still not sure what to make of the new science, Colvin said, “these companies have a great responsibility right now to do the safety testing and, to the extent possible, make those findings public.”"

The hearing comes on the heals of an assessment of the National Nanotechnology Initiative (NNI), a report that was required by the 2003 act authorizing federal funding for nanotech R&D. This law called for a National Nanotechnology Advisory Panel to conduct the assessment. In 2004, President Bush designated PCAST as the NNAP.

The law requires NNI activities to integrate research on ethical concerns surrounding nanotechnology into R&D activities, and requires the NNAC (now PCAST) to assess “whether societal, ethical, legal, environmental, and workforce concerns are adequately addressed by the [NNI]” and to make recommendations for improvement. The PCAST report, however, can be interpreted as fairly insubstantial in its treatment of how ethical concerns are being addressed (see Howard Lovy’s entertaining summary). For instance, in stressing the role of “sound science” over “perceived fears,” the language of the report appears to downplay the role of ongoing ethical assessment with respect to R&D activities.

During the hearing, PCAST co-chairman Floyd Kvamme, one of the witnesses, suggested that health, safety, and environment issues are mostly workplace related. For example, employees who install nanotubes into, say, tennis balls may face heath and safety risks. Yet, once the nanotubes are in the tennis ball, Kvamme stated, “we are far less concerned because of the technology involved there.” (By contrast, another hearing witness, Matthew Nordan, stated “the truth is we don’t know right now” whether the nanotubes in a given product may separate from their composite matrix after 20-50 years in a landfill).

Towards the end of the hearing, House Science committee member Brad Sherman had a telling exchange with the PCAST co-chairman. Asked what the administration was doing to carry out the mandate to study the potential impacts of nanotech activity, Kvamme referred to a popular work of science fiction that has come to epitomize the “perceived fear” of nanotechnology.

Later, Kvamme defended the decision not to assess the NNI with respect to ethical issues concerning artificial intelligence – issues mentioned explicitly in the 2003 act – on the grounds that research projects do not appear at present to be “going on.” Sherman responded that the provision to study the impacts of such projects “weren’t designed to become operative a year before [they] were technologically possible.”

At one point, Sherman stated “you’re supposed to be looking at the societal problems and you’re looking at the technological capacity.” In other words, “[you] don’t want to study the societal problems of doing it, [you] want to study how to do it.”

The dichotomy between “science” and “perception” can sometimes suggest an unduly high level of certainty. Consequently, ethical concerns that extend beyond the scientific capacity to address them may fall into the category of unscientific or even irrational, and may be largely dismissed. One problem with this is that real risks and significant impacts that are slow to emerge can be ignored until it is too late to effectively address them. On the other hand, popular perceptions and concerns about an emerging science can certainly be wildly inaccurate. To simply ignore these concerns, however, is to dismiss consumer and taxpayer perceptions, which can undermine commercialization efforts.

The ethics policy that the NNI ultimately adopts will in many ways involve what perspectives on uncertainty happen to be prevalent – for instance, how much legitimacy policymakers grant to the uncertainty surrounding various specific ethical concerns, or the degree to which they consider it important to focus on reducing regulative uncertainty, which can also undermine commercialization.

Another key factor will entail who actually makes the decisions. The congressional authorizing committee upon which Sherman sits contributed to the law’s language about ethical concerns. There is a running debate on what authority congressional authorizing committees actually have in comparison to congressional appropriations committees (a nice follow up post here on Prometheus?). Implementation of the law rests with administrative agencies and committees. When Sherman somewhat sarcastically wondered out loud whether “authorizing committees, even when successful in getting their language into law, are not in a position to influence administrative policy,” the PCAST co-chairman responded, “possibly not.” Needless to say, the congressman didn’t take well to the implication that authorizing committees may simply be “wasting [their] time.”

A webcast of the hearing, entitled “Nanotechnology: Where Does the U.S. Stand?,” is available here.

They write:

“While making obvious improvements in control and operation of the grid, we should focus the greater part of our effort on fulfilling the mission of the electricity system, not on trying to prevent blackouts. When hurricanes, tornadoes, ice storms or other problems black out the system, backup generators at hospitals, airports and other critical institutions prevent their missions from being interrupted.”

The editorial suggests a very different approach than that being articulated in Washington, such as using cost-effective and creative engineering approaches to accomplish critical missions. It ends with listing four tasks to accomplish their proposed objectives:

“The first task is to list the important missions that are accomplished by the electricity system. The second is to rank these missions in order of priority. Third, we must identify which missions are already protected. The fourth and final task is to find cost-effective ways of accomplishing the most important missions when the power fails.”

The report has occasioned editorials such as one posted on SciDev.Net by David Dickson.

Dickson suggests the report points to two key challenges facing nanotechnology and nanoscience: adequately ensuring that nanotechnologies address the needs of the world’s poor and building social markets favorable to nanotechnologies.

To address the risk of a “nano-divide” between the world’s rich and poor nations, Dickson calls for the development of nanotech skills among poorer nations, dissemination channels for nano products, and informed public debate.

Characterizing the content of this debate, Dickson writes: “informed public debate…must include authoritative information about potential health and environmental consequences; there is no room for those who dismiss all such concerns as merely the unreasonable demands of whose who seek a risk-free society.”

It is not always clear on what basis information should be considered “authoritative” nor who should decide this. The approach outlined by Dickson would seem to include information and demands that might otherwise be disqualified on the grounds of being “unreasonable.” This type of approach may be encouraging to those who would make such demands, but it stops short of outlining what counts as “reasonable.”

While defining “reasonable demands” is risky business, without clear parameters, what gets debated could too easily be determined by the agendas of those who get to decide, rather than by a reasonable process.

There are serious considerations involved in allowing a potential onslaught of such lawsuits, including their possible effect on health costs, the availability of medical products on the market, and the possibility that states would reach different conclusions regarding the safety of a medical device.

According to the article, the administration states that different conclusions would lead to “chaos for the regulated industry and F.D.A.” That may be so, and yet this possibility raises grave questions about the goal of having clear and straightforward regulatory policy if it comes at the expense of credibility in the eyes of the public.

The administration is banking on the credibility of the FDA: “if” (according to the article) “a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation.”

Surely, expensive and rigorous testing must count for something. But for how much? Unassailability on the part of the product once it has been approved? That argument may work when the buyer is held responsible for his or her decision to purchase and use a product. But making the FDA responsible arguably takes the responsibility away from the consumer and undercuts the “buyer beware” argument.

The case is complicated (alas, not simplified) by the role of expertise, namely scientific expertise. The government position is based on the belief that consumer lawsuits would “interfere with federal regulation of drugs and devices, by encouraging “lay judges and juries to second-guess” experts at the F.D.A.” (ibid).

Deciding that “tested” science is unassailable is not quite the same as deciding that “proven” science is unassailable. Few today would endorse dragging Galileo or his contributions to trail. Furthermore, no one wants to see competent science and engineering innovations senselessly punished. Yet, circularly making medical drugs and devices immune from lawsuits on the grounds of the scientific expertise that underlies them amounts to technocratic tyranny.

Should attending to the need for clear regulation come at the cost of the need for such regulation in the first place?